Hemodialysis Machine Blood Pump Rotor Guide Sheave Failure Recall
Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with no reported illnesses or injuries in the source material. The hazard—loose or dislodged rotor components—represents a risk-of-harm to dialysis patients, but the complaint is of potential equipment failure rather than documented patient injury.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Blood Pump Rotor component (Model F40015481 Rev A) used in the 2008T BlueStar Hemodialysis Machine (Model 191130). Approximately 11,371 units have been distributed nationwide in the United States.
After a period of clinical use, Fresenius received an increased number of complaints indicating that the guide sheaves in the Blood Pump Rotor became loose or dislodged. Guide sheaves are structural components of the pump rotor, and their failure could compromise the machine's ability to function properly during patient treatment.
Healthcare facilities using affected machines should contact Fresenius Medical Care for guidance on inspection, service, or replacement of the affected component. Patients undergoing hemodialysis treatment should consult with their healthcare provider regarding any impacts to their scheduled treatments.
The recalled product
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- loose-component
- mechanical-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Component: Model Number: F40015481 Rev A
- UDI/DI: N/A
- All Rev A lots. Finished Devices: Model Number: 191130
- UDI/DI: 00840861102112
- Serial Numbers: 2T0S265095
- 2T0S265131
- 2T0S266383
- 2T0S266406
- 2T0S266459
- 0T0S251328
- 0T0S251333
- 0T0S251334
- 0T0S251335
- 0T0S251337
- 0T0S251338
- 0T0S251343
- 0T0S251345
- 0T0S251347
- 0T0S251348
- 0T0S251349
Distribution
Distributed nationwide across the United States.
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